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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Led Light Source
510(k) Number K103813
Device Name SOPRO 281
Applicant
Sopro
124 Gaither Dr. Suite #140
Mt. Laurel,  NJ  08054
Applicant Contact RICK ROSATI
Correspondent
Sopro
124 Gaither Dr. Suite #140
Mt. Laurel,  NJ  08054
Correspondent Contact RICK ROSATI
Regulation Number876.1500
Classification Product Code
NTN  
Subsequent Product Code
FCW  
Date Received12/29/2010
Decision Date 03/22/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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